510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K926349Substantially Equivalent

Probloc Insulated Needles

Life-Tech Intl., Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926349 is the FDA 510(k) clearance record for PROBLOC INSULATED NEEDLES, a class II device, cleared for Life-Tech Intl., Inc. on under FDA product code GXZ (Electrode, Needle). FDA records list 68 510(k) clearances for Life-Tech Intl., Inc., from to . As of , FDA records show no recalls naming K926349.

Clearance record

Decision date
Received
(224 days to decision)
Product code
GXZ Electrode, Needle
Regulation
21 CFR 882.1350
Device class
Class II
Review panel
Neurology
Applicant
Life-Tech Intl., Inc. P.O. Box 36221, Houston TX
510(k) summary
Statement
Third party review
No

Clearances, product code GXZ

Trailing 12 months

FDA records hold no clearances under product code GXZ in the trailing twelve months.

FDA records show no clearances under product code GXZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260